Trials / Completed
CompletedNCT03628339
Effect of Tepotinib on PK of CYP3A Substrate Midazolam
Phase 1, Open-label, Single Sequence, Two-Period Crossover Trial to Evaluate the Effect of Tepotinib on CYP3A by Investigating the PK of the CYP3A Substrate Midazolam in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 18 Years – 44 Years
- Healthy volunteers
- Accepted
Summary
The study investigated the effect of tepotinib on the pharmacokinetics (PK) of the Cytochrome P450 (CYP) 3A substrate midazolam determined from concentrations of midazolam and its main metabolite 1-hydroxymidazolam in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Midazolam | Participant received single oral dose of 7.5 mg midazolam tablet on Day 1 of treatment period 1 and Day 11 in treatment period 2. |
| DRUG | Tepotinib | Participants received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 in treatment period 2. |
Timeline
- Start date
- 2018-08-20
- Primary completion
- 2018-10-25
- Completion
- 2018-10-30
- First posted
- 2018-08-14
- Last updated
- 2023-07-28
- Results posted
- 2023-07-28
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03628339. Inclusion in this directory is not an endorsement.